New Swissmedic Class 1 MDR Device Labeling Requirements
The Swissmedic guidance mandates the inclusion of CH-REP (Swiss Responsible Person) information on the labels of Class…
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MDD Declaration of Conformity After 26 May 2021
As a regulatory representative for foreign manufacturers in the EU, UK, US, and Switzerland, MedEnvoy participated in several audits with…
Swissmedic Audit Reveals Compliance Issues with Class I Medical Device Manufacturers
Swissmedic, as expected, has started auditing and inspecting relevant economic operators. For example, Swiss-authorized representatives were subject to systematic…
Swissdamed: Swiss Database on Medical Devices
Swissmedic has officially announced the launch of…
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